Reference number (b)(4).Catalog number is the similar us list number, the international list number is unknown.The device manufacturer and lot number of the device involved in this complaint was not provided.Therefore, it is unknown if the device involved was abbvie branded tubing.Abbvie has chosen to report this complaint due to the potential that the device involved could have been abbvie branded tubing.The device involved in the event was discarded and was not returned; therefore, a return sample evaluation is unable to be performed.Buried bumper is a known complication of a peg- j tube placement.(b)(4).A buried bumper is a known complication of a peg tube placement.Instructions for use indicates once the stoma site is healed, the abbvie peg tube should be mobilized.Push the abbvie peg tube carefully 3-4 cm into the stoma and move the tube in a bi-directional motion (back and forth) every time the dressing is changed.When doing so the tube should not be turned or rotated under any circumstances to prevent the formation of loops and dislocation of the abbvie j tube.It is important for the tube to move freely in the stoma to prevent the internal retention plate from becoming embedded (¿buried bumper syndrome¿).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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